Ex Parte Hori et al

Board of Patent Appeals and Interferences

May 7, 2010

10411822 (B.P.A.I. May. 7, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MITSUHIKO HORI, KEIJI YAMAMOTO,
KENSUKE MATSUOKA, and YOSHIHISA NAKANO
__________

Appeal 2009-012117
Application 10/411,822
Technology Center 1600
__________

Decided: May 7, 2010
__________

Before ERIC GRIMES, LORA M. GREEN, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-11. We have jurisdiction under 35 U.S.C.
§ 6(b).

Appeal 2009-012117
Application 10/411,822

STATEMENT OF THE CASE
Claim 1 is representative of the claims on appeal, and reads as
follows:
1. A patch comprising a substrate, a non-crosslinked adhesive layer (A)
containing a drug other than 2-amino-1-(2',5'-dimethoxyphenyl)ethanol and
a pharmacologically acceptable salt thereof, which is laminated on one
surface of the substrate, and a crosslinked adhesive layer (B) laminated on
the adhesive layer (A),
wherein the adhesive layer (A) comprises 25-200 parts by weight of
an organic liquid component per 100 parts by weight of the adhesive in the
adhesive layer (A), and
wherein the adhesive layer (B) comprises 25-200 parts by weight of
an organic liquid component per 100 parts by weight of the adhesive in the
adhesive layer (B).

We affirm.

ISSUES
Does the preponderance of evidence of record support the Examiner’s
conclusion that the combination of Quan and Akemi renders the patch of
claim 1 obvious?
If yes, have Appellants demonstrated unexpected results that when
weighed with the evidence of obviousness, are sufficient to demonstrate the
nonobviousness of the patch of claim 1?

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FINDINGS OF FACT
FF1 The Examiner rejects claims 1-11 under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Quan1 and Akemi.2 (Ans. 3.) As
Appellants do not argue the claims separately, we focus our analysis on
claim 1, and claims 2-11 stand or fall with that claim. 37 C.F.R. §
41.37(c)(1)(vii).
FF2 The Examiner finds that Quan teaches a transdermal patch comprising
an adhesive matrix containing a drug and a backing layer. (Ans. 3.)
FF3 The Examiner finds that the “adhesive matrix is preferably acrylic
adhesive that can be crosslinked or uncrosslinked,” and “is laminated or
overlaid with adhesive layer,” wherein the adhesive matrix further comprises
plasticizers. (Id.)
FF4 The Examiner thus find that Quan teaches: 1) a backing layer; 2) an
adhesive matrix comprising a drug which can be uncrosslinked; and 3) an
overlaid second adhesive layer that can be crosslinked, that is preferably an
acrylic copolymer adhesive. (Id. at 7.)
FF5 Specifically, Quan teaches a matrix patch that comprises a polymer
layer containing a biocompatible polymer, a percutaneously absorbable basic
drug, and a permeation enhancer. (Quan, col. 3, ll. 45-54.)
FF6 Quan teaches that the polymer layer is preferably an adhesive, but can
be used with an overlay adhesive. (Id. at col. 3, l. 55-col. 4, l. 1.)
FF7 Quan teaches that suitable polymers include acrylics, and that the
matrix may contain diluents, excipients, emollients, plasticizers, skin

1 Quan, U.S. Patent No. 5,601,839, issued February 11, 1997.
2 Akemi, EP 0531938 A1, published March 17, 1993.
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Application 10/411,822

irritation reducing agents, carriers, and mixtures thereof. (Id. at col. 4, ll. 1-
10.)
FF8 Quan teaches that suitable adhesives include acrylic adhesives
including cross-linked and uncross-linked acrylic copolymers. (Id. at col. 6,
ll. 58-60.)
FF9 Quan notes that suitable diluents can include mineral oil, low
molecular weight polymers, plasticizers, and the like, and that a preferred
skin irritation reducing agent is glycerin. (Id. at col. 7, ll. 33-45.)
FF10 The Examiner notes that while Quan teaches that the acrylic adhesive
can be crosslinked, and also teaches that plasticizers and diluents such as
mineral oil may be included, Quan does not teach the specific amount of
organic liquid in the two adhesive layers. (Ans. 3.)
FF11 The Examiner relies on Akemi for teaching acrylic adhesive
preparations that contain plasticizers such as glycerin esters, isopropyl
myristate, or isotridecyl myristate, in the amount of 25 to 200 parts by
weight per 100 parts by weight of the acrylic ester-based polymer. (Id. at 4;
see also Akemi at 4-5.)
FF12 The Examiner finds that Akemi teaches that the “crosslinked acrylic
based copolymer adhesive containing plasticizer . . . has good balance
between adhesion to the skin and skin-unstimulating properties and shows
soft adhesion to the skin and it eases the stress to be imposed on the skin
when the adhesive layer is stripped from the skin.” (Ans. 4.)
FF13 Akemi teaches that the pressure-sensitive adhesive having such
properties as a liquid ingredient compatible with the polymer
is incorporated in an amount larger than normal amounts, and
the polymer is crosslinked to allow it to gel to a degree such
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Application 10/411,822

that the resulting pressure-sensitive adhesive layer has a gel
content in a specific range, thereby to remedy the decreased
cohesive force due to the incorporation of the liquid ingredient
and, at the same time, to enable the pressure-sensitive adhesive
to show soft adhesion to the skin and to ease or disperse a stress
to be imposed on the skin when the adhesive layer is stripped
from the skin.

(Akemi at 2-3.)
FF14 Akemi teaches further:
The amount of the liquid component contained in the
pressure-sensitive adhesive layer is generally from 25 to 200
parts by weight, preferably from 40 to 160 parts by weight,
more preferably from 100 to 160 parts by weight, per 100 parts
by weight of the acrylic ester-based polymer. When a liquid
component is contained in the crosslinked pressure-sensitive
adhesive layer in a large amount as in the case of the present
invention, the adhesion strength (interfacial adhesion strength)
of the pressure-sensitive adhesive layer to the skin becomes
lower than the bonding strength among horny layer cells, so
that stripping of the pressure-sensitive adhesive layer from the
skin does not result in peeling of horny layer cells.

(Id. at 5.)
FF15 The Examiner concludes that it would have been obvious to use a
cross-linked acrylic adhesive layer as taught by Akemi for the overlying
adhesive layer of Quan because Akemi teaches that crosslinked acrylic
based copolymer adhesives containing plasticizer have a good balance
between adhesion to the skin and skin-unstimulating properties and shows
soft adhesion to the skin and eases the stress to be imposed on the skin when
the adhesive layer is stripped from the skin. (Ans. 4-5.)

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Application 10/411,822

ANALYSIS
Appellants note that the claimed invention requires:

(App. Br. 5). Appellants then assert that Quan teaches:

and Akemi teaches:

(id. at 5-6).
According to Appellants, Quan teaches that the adhesive may be
cross-linked or non-crosslinked, but “does not exemplify or recognize any
benefit of providing a non-crosslinked adhesive comprising a drug compared
to a crosslinked adhesive comprising a drug,” much less any advantage
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Application 10/411,822

“when a non-crosslinked adhesive comprising a drug is diposed between a
substrate and a crosslinked adhesive layer.” (Id.) Appellants assert that
Quan places equal emphasis on cross-linked and non-crosslinked adhesives,
and that “[w]ithout any teaching of, or pointer to, a non-crosslinked
adhesive, one of ordinary skill in the art would have no reason to chose [sic]
a non-crosslinked adhesive to contain the drug as compared to a crosslinked
adhesive.” (Id. at 8.) Appellants make similar arguments as to the second
adhesive layer that does not contain the drug, that is, as Quan teaches the use
of both a crosslinked and non-crosslinked adhesive, the ordinary artisan
would have no reason to choose the crosslinked adhesive. (Id.) Thus,
Appellants assert, that if the ordinary artisan were in fact to combine Quan
and Akemi, one would arrive at the following patch:

which contains two crosslinked layers. (Id. at 9.)
Akemi, Appellants assert, “teaches the benefits of using a crosslinked
pressure-sensitive adhesive layer that is in direct contact with a substrate,”
and thus teaches away from the claimed invention. (Id. at 6.)
In combining the references, Appellants argue, the Examiner, in
essence, is merely stating “that it would be possible for one of ordinary skill
in the art to arrive at the present invention by following the disclosures of
the cited references and trying various combinations and permutations,” and
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Application 10/411,822

it is clear under KSR that a claimed invention is not rendered obvious just
because all of the elements are independently known in the art. (Id. at 7.)
According to Appellants, the Examiner did not provide a reason to combine
Quan and Akemi to arrive at the claimed invention. (Id. at 8.)
Appellants’ arguments are not convincing. Quan teaches a patch
comprising a substrate, a crosslinked or non-crosslinked adhesive matrix that
contains the active agent (i.e., the drug to be delivered by the patch), and a
crosslinked or non-crosslinked overlaid adhesive layer. Akemi provides a
reason to use a crosslinked overlaid adhesive layer, in that such an adhesive
layer “has good balance between adhesion to the skin and skin-unstimulating
properties and shows soft adhesion to the skin and it eases the stress to be
imposed on the skin when the adhesive layer is stripped from the skin.”
(FF12.) The reasons for adding a cross-linked layer as taught by Akemi
therefore apply to the layer facing the skin, and not to the substrate. Thus
we conclude that the combination of Akemi and Quan renders obvious a
patch comprising a substrate, a crosslinked or non-crosslinked adhesive
matrix that contains the active agent (i.e., the drug to be delivered by the
patch), and a crosslinked overlaid adhesive layer. Thus, in the absence of
unexpected results, the combination as set forth by the Examiner renders
obvious the patch of claim 1. See, e.g., KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 419 (2007) (“What matters is the objective reach of the claim. If
the claim extends to what is obvious, it is invalid under § 103.”).
Appellants argue further that each of the claims on appeal requires
that each of the adhesive layers comprise “25-200 parts by weight of an
organic liquid component per 100 parts by weight of the adhesive in the
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Application 10/411,822

adhesive layer (A) and adhesive layer (B), respectively.” (App. Br. 9.)
Quan, Appellants argue, “does not disclose or suggest the addition of any
specific amount of an organic liquid component to an adhesive layer,” and
Akemi “discloses the addition of a specific amount of an organic liquid
component to a crosslinked acrylic copolymer adhesive.” (Id.) Appellants
assert that Akemi “warns that the addition of an absorption-promoting agent
to a preparation can adversely affect the tackiness properties of the adhesive
layer or the stability of the drug,” and thus the ordinary artisan would not
add an organic liquid component to a non-crosslinked adhesive layer. (Id. at
9-10 (citing page 2 of Akemi).)
Appellants’ arguments are again not convincing. Quan teaches that
the adhesive matrix may be crosslinked or non-crosslinked, wherein the
matrix may include diluents, excipients, emollients, plasticizers, skin
irritation reducing agents, carriers, and mixtures thereof. Thus, Quan
teaches that organic liquids may be added to an adhesive matrix that is
crosslinked or non-crosslinked. Akemi teaches that organic liquids are
added to a crosslinked adhesive in greater than normal amounts, preferably
from 100 to 160 parts by weight, in order to form a gel pressure-sensitive
adhesive layer that has a gel content in a specific range, thereby to remedy
the decreased cohesive force. Thus, Akemi does not teach away from
adding an organic liquid to a non-crosslinked layer, but teaches the
advantage of adding higher than normal amounts of such a liquid to a
crosslinked adhesive layer. Given that Quan teaches that organic liquids
such as diluents, excipients, emollients, plasticizers, skin irritation reducing
agents, carriers, and mixtures thereof may be added to a non-crosslinked
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Application 10/411,822

adhesive matrix, it would have been well within the level of skill of the
ordinary artisan to add and optimize the amounts of such organic liquids to
the adhesive matrix containing the active agent.
Appellants assert further that there is objective evidence of non-
obviousness. (App. Br. 6.) Citing pages 3 and 14 of the Specification,
Appellants assert that they “have surprisingly found that when (a) a patch
comprises a substrate, a non-crosslinked adhesive layer (A) containing a
drug, and a crosslinked adhesive layer (B) and (b) the aforementioned
components are laminated in the aforementioned order, the percutaneous
absorbability of the drug is improved, and the patch is free of problems such
as adhesive residue and adhesive bleed.” (Id. at 6-7.)
Pages 3 and 14 of the Specification, however, do not present any
objective evidence supporting the above purported unexpected results. The
burden of demonstrating unexpected results rests on the party asserting
them, In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). In addition, it is
well settled that results must be established by factual evidence. Mere
argument or conclusory statements in the Specification do not suffice. In re
De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Thus, Appellants have not
presented unexpected results that when weighed with the evidence of record
supporting the prima facie case of obviousness, are sufficient to demonstrate
the nonobviousness of the patch of claim 1.

CONCLUSIONS OF LAW
We conclude that the preponderance of evidence of record supports
the Examiner’s conclusion that the combination of Quan and Akemi renders
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Application 10/411,822

the patch of claim 1 obvious. We conclude further that Appellants have not
demonstrated unexpected results that when weighed with the evidence of
obviousness, are sufficient to demonstrate the nonobviousness of the patch
of claim 1.
We thus affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
being rendered obvious by the combination of Quan and Akemi. As claims
2-11 stand or fall with claim 1, we affirm the rejection as to those claims as
well.
The Examiner also rejects claims 1-11 on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 1-9 of
copending application 10/454,629. As Appellants merely assert that the
rejection should be reversed if the obviousness rejection over Quan and
Akemi is reversed (App. Br. 11), we affirm this rejection as well.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED

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